Principles for the first year of system regulation

Background

The regulatory landscape in the health and care system has evolved significantly over the past two decades. Organisations have frequently been created, disbanded, replaced, rebranded or repositioned within a constellation of arm’s-length-bodies, ‘watchdogs’, parliamentary offices and internal regulators.

In addition to this complexity, a desire to maintain both a national and regional presence has created a confusing picture of regulation for health and care services, leading to fragmentation and a lack of coordination.

Additional issues arising from such a configuration are the potential for burdensome ways of working and poor value for taxpayers. More importantly, a greater risk exists of identifying and mitigating issues of poor quality care if the regulatory construct is not sufficiently well designed.

Our members – the organisations that plan, commission and provide NHS services in England – regularly share concerns about the gap between the strategy and expectations of national regulators and their experience of regulation on the ground.

In a survey of ICS leaders from 35 systems, oversight and regulation was cited as one of the five biggest obstacles to system progress.

This report sets out a set of principles we have developed based on conversations with our members and regulators over the past year. We believe these principles should drive the actions of regulators over this crucial first year of system regulation and oversight.

Who are the regulators?

The term regulator here refers to national and professional regulators. National regulators include the Care Quality Commission and NHS England and NHS Improvement (NHSEI). While the CQC monitors, inspects and regulates services to ensure they meet quality and safety standards, NHSEI assures and oversees health and care organisations. It also holds various functions, such as system delivery, facilitation and support. 

There is a subtle distinction to be drawn between the foundational principles of regulation and assurance: while regulation is first and foremost about protecting patients, assurance is about driving delivery for patients and taxpayers. The outcome of both should be improving patient care. NHSEI’s and the CQC’s frameworks should be aligned as far as possible to provide clarity and avoid duplicating regulation and oversight processes; as will any new oversight framework stemming from the government’s integration white paper. Our briefing further analyses the white paper’s implications for regulation and oversight arrangements.

Professional regulators include organisations such as the General Medical Council, the Nursing and Midwifery Council and the Health and Care Professions Council. Professional regulators have a key role in supporting integration by stipulating what clinical standards, training and professional development is needed to support the new system architecture, as well as contributing data and insight to identify and act on emerging concerns before they escalate. 

As ICSs – in particular through integrated care partnerships, which include partners in education, the justice system and beyond – encompass local government and third sector bodies, they will also come into contact with regulators including Ofsted and Her Majesty’s Inspectorate of Prisons. Regulation of systems therefore needs to recognise these complex relationships and different accountability lines.

System working will demand new models of regulation and oversight

The widely supported vision set out in the health and care bill moves the health and care system towards new, more integrated ways of working at the local level. A government amendment to the bill confers powers on the CQC to assess ICSs and local authority-provided social care. If successful, this legislative framework will ensure that from July 2022, local changes and decisions are made at the most appropriate level. It will also ensure that the NHS works more meaningfully with partners in social care, housing, education and the wider public sector to improve population health and reduce inequalities. Ultimately it intends to make sure that individuals receive care from different parts of the system in a more streamlined and person-centred way. With a vision to join up decision-making and provision between organisations at a place and system level, there is significant scope to provide a more person-centred model of care.

However, if these benefits are to be reaped, leaders in integrated care systems will need the time and space to embed new structures and ways of working. There is a risk that overly burdensome and bureaucratic regulation and oversight will hinder progress, especially during this crucial phase. 

ICS leaders have the clearest view of what an ICS does, how it works and the solutions to the problems it faces. It therefore follows that they should be enabled to drive their own improvement

One of the biggest challenges for ICS leaders is ensuring they have sufficient leadership and managerial time to lead and support the delivery of local priorities for transformation. It is therefore critical that the system regulation/oversight regime operates in a way that allows senior leaders and other staff to focus sufficient time on delivering lasting improvement alongside appropriate reporting and addressing short-term operational issues. 

ICS leaders have the clearest view of what an ICS does, how it works and the solutions to the problems it faces. It therefore follows that they should be enabled to drive their own improvement. Many of our ICS members advocate for peer-to-peer approaches, which they see as offering credibility and impact to the process of system regulation/oversight and driving improvement. The shift to ICSs and partnership working will require a huge behavioural shift and change in leadership styles. Integrated care board level peer review could offer a robust assessment of relationships and partnerships. 

The experience of local government colleagues has shown that peer review is not a light touch improvement model and will be challenging and uncomfortable, but the conversations it provokes are critical. It can be powerful and supportive improvement methodology, ensuring that outcomes are owned by the system and something leaders have to respond to. Our conversations with regulators over the past year have shown a clear appetite and willingness to consider the role of peer review in system regulation and oversight.

System regulation should add value to that of organisational regulation by regulating organisations based on their ability to work collaboratively in systems, embodying a ‘system first’ approach. There should also be a recognition that integrated care boards will carry out quality assurance of the providers they commission, as clinical commissioning groups (CCGs) did, adopting a ‘co-regulator’ role. 

Regulators should consider the role of the integrated care partnerships, which will be responsible for delivering on key ICS priorities, including the integrated care strategy (and additional responsibilities which may well be delegated from the integrated care board). ICPs are partnership bodies with a remit that goes beyond NHS activities, requiring a much wider framework of accountability into local government and wider local civil society. 

The integrated care board and local authorities – the two partners of the integrated care partnership – will be responsible both for commissioning services and assuring the quality of these services. This co-regulatory role and relational dynamics must be a key consideration for regulators when developing their approaches to the constituent parts of the ICS.

System working provides an opportunity to regulate differently, by driving improvement across systems, focusing on whole patient pathways, and reinforcing partnership working. There must be a recognition that this needs to happen iteratively and collaboratively and will not be fully functioning from day one.

Ultimately, for these new ways of working to be realised, the role, remit and configuration of regulatory bodies and their activities will need to evolve to adequately support this approach. 

Developing a set of system regulation principles

From our conversations with members, regulators and representatives from local government over the past year, there is perceptible agreement that a more cohesive approach is needed to avoid creating additional layers of regulation and a shared appetite to move towards facilitating improvement across systems, as well as upholding standards. Based on these conversations, we have developed a set of principles which we believe should drive the actions of regulators. 

We have consulted with members on these principles so that future regulation constructs are driven by system leaders. If regulators implement these principles, we believe it will provide clarity to leaders of ICSs and the NHS organisations within them about what they can do and what is expected of them. In particular, we hope they will feed into regulators’ frameworks and methodologies for assessing ICSs. 

The principles

1. Regulation should aim to protect the public and the taxpayer

The focus of regulation must be on improving people’s access, experience and outcomes. Patients and their families should feel reassured that the services offered are safe and effective. Taxpayers should feel that oversight/assurance is efficient and cost-effective.

2. Alignment of intent

Systems and organisations within them should have a clear picture of which regulators are active in their patch and what their areas of focus are.

3. Improvement focused

Our members tell us language and framing, as well as subsequent behaviours, are important in building trust with regulators – system regulation should go beyond a top-down intervention and also help promote improvement.

4. Centring culture and behaviour

The success of integration will depend on cultural and behavioural change; both regulators and ICSs working on this will lead to the kind of mutual confidence and respect needed to allow system working to thrive.

5. Supporting integration

System regulation should reinforce the intention of policy/legislation on collaboration and integration to enable local leaders to lead and innovate.

6. Proportionality

Intervention should be proportionate and risk based; system leaders should feel that they are involved in the design of their inspection and package of support and be assured that regulators are sensitive to the pressures and challenges they face.

7. Diversifying assessment and intervention methods

Inspections are not the only way to assess quality/safety, although they will sometimes be necessary. Interventional action should be predominantly owned by the system and associated with bespoke, high-quality external support. There is clear support for new models of intervention, particularly peer review and support within a clear and challenging national framework.

8. Streamlining smart use of data and inspection regimes

smart use of data avoids duplication and allows earlier intervention, preventing issues from becoming protracted. Sharing insight allows learning and dissemination of best practice.

9. Embedding feedback mechanisms

Regulators must be able to reflect the complexity of activity happening in ICSs back to the system to support learning and improvement – it will be especially important to maintain a consistent feedback loop with ICS leaders.

Delivering against the principles

Below each principle we have laid out the steps we think regulators should take to get there. 

1. Regulation should aim to protect the public and the taxpayer

• Provide clear information to the public on their role in system regulation and reflect their concerns back to both the public and those providing care within the system.
• Ensure regulatory activity is coordinated, efficient and cost effective.

2. Alignment of intent

• Clearly communicate their different roles and responsibilities from the outset to prevent overlap or acting at cross purposes.
• Speak with one voice, working together to drive improvement and avoid duplicate interventions being imposed at the same time when issues arise.
• Provide clarity on whether accountabilities for activities they regulate lie within the integrated care board, at provider level or at place.

3. Improvement focused

• Drive improvement through a focus on outcomes, not just inputs, with an emphasis on enabling progress towards reducing health inequalities and the four purposes of ICSs.
• Improve sharing of data and insight to get a picture of issues as they emerge, so they can have a more up-to-date picture of the care patients are receiving and intervene before things have become intractable.
• Focus on longer-term transformation of services which will drive lasting improvements in performance including, for example, preventative and anticipatory care – not just shorter-term considerations such as systems’ financial and quality challenges.

4. Centring culture and behaviour

• Foster a culture of trust, openness, learning and improvement through sharing, embedding quality and stimulating behaviour change.
• Think carefully about how internal cultural and behaviour change will be necessary to drive improvements in regulated services, including training of inspection staff.
• Ensure consistency and alignment in leadership behaviours across ICSs and the organisations regulating/assuring them.
• Embolden and support local leaders to lead and innovate, giving them autonomy to lead change and hold responsibility for delivering solutions to local challenges.

5. Supporting integration

• Produce effective assessment regimes for systems and pathways rather than just organisations within a system/pathway. This will be especially important in system-wide work to tackle health inequalities and embed innovation, which should be guided by the principle of earned autonomy.
• Give ICSs space to do these things, reward working well with other partners within the system and encourage pooling of resources to tackle issues.
• Educate regulatory staff on the evolving landscape and keep up to date with system development through regular engagements with leaders across the system.
• Use a ‘system first’ approach and regulate/assess individual organisations within the ICS on their ability to work in systems.
• Be sensitive to other system partners’ sector specific regulatory activities and models of accountability.

6. Proportionality

• Create a regulatory environment that is lean, light and agile, but which still focuses on outcomes and improvement.
• Be mindful of the context they are operating in and ensure the level of oversight or intervention is aligned with the challenges facing the system, such as COVID-19 waves and winter pressures.
• Consider what proportionality looks like from the perspective of the receiver and involve them in inspection and support co-design.

7. Diversifying assessment and intervention methods

• Consider how system leaders can be empowered to find their own solutions and drive their own improvement, for example by defining the metrics they will be assessed on based on local priorities and by allowing ICS peer review to have a clear role, either alongside or replacing some elements of existing regulatory regimes, being aware that regulatory approaches may need to adapt to avoid duplication.
• Actively support peer review driven by ICS leaders, by imparting data, skills and understanding of processes.

8. Streamlining smart use of data and inspection regimes

• Aggregate information and data requests to avoid duplication.
• Reduce the bureaucratic burden placed on provider organisations, systems and service users by moving towards establishing one common data set for all.

9. Embedding feedback mechanisms

• Regulatory frameworks and guidance should be co-created with system leaders and service users (for example through Healthwatch). 
   

Next steps

Facilitating feedback loops between regulators and system leaders is one of the key roles our members want us to play. We will continue to work closely with members so that these principles are reflected in their experience of regulation and to ensure they are given ample opportunity to co-design regimes of regulation and oversight. We will continue to reflect and amplify their feedback, experiences and concerns, and drive conversations around peer review. 

ICSs should be involved in steering and leading the peer review process and we will support ICS colleagues who wish to do so. We are working with the Local Government Association and NHS Providers to deliver a menu of peer support tailored to the needs of systems, which we hope ICS leaders will take up this offer over the coming years.

We will continue to support regulators to improve these regimes and intend to meet in 2022 to consider progress against these nine principles and evolve them as necessary.

The position of these principles within system working will depend to an extent on the legislative framework, including any amendments to the health and care bill and the policy and/or legislative changes enacted as a result of the integration white paper. We will continue to work closely with the department of health and social care and parliamentarians to secure frameworks that our members support.